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510(k) K181537

GLOW800 by Leica Microsystems (Schweiz) AG — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2018
Date Received
June 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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